Formedix talk at CDISC US 2016
Held on the doorstep (almost) of the Food and Drug Administration (FDA), and with demanding changes to FDA regulations on the horizon, Formedix is delighted to participate the Interchange again this year.
Hosting the Formedix booth #16 during main conference days on September 28-29, CEO Mark Wheeldon shares his thoughts: “We continue to participate in the International Interchange each year. It’s a perfect opportunity to meet with industry colleagues and meet new organizations at the start of their data standards journey. I expect it will be a busy show this year, with such significant changes ahead.”
FDA regulatory changes are afoot, including a requirement for the the use of CDISC standards in electronic submissions, support for Define-XML v1.0 ending, with a move to Define-XML v2.0, in the near term. The CDISC Interchange is a perfect opportunity for organizations to discuss how they will be affected, how they can prepare, and how they keep up with the pace of regulatory change.
Wheeldon continues: “During the Interchange we expect to generate a great deal of interest in our platform, as organizations begin their preparations. In particular, I anticipate that our SDTM conversion tools and our CDISC training will have the most appeal.”
Formedix data conversion tools
Formedix dataset conversion tools turn your datasets into CDISC submission-ready formats – as well as producing essential documents such as Define-XML 1.0 and Define-XML 2.0. If you reviewer requires Define.PDF we also have a handy Publish Define-XML as PDF utility.
Get fortnightly content on regulatory compliance, metadata management & more!